ANZCTR search results

Paediatric bone deformities can result from congenital conditions or acute injuries and often require orthopaedic intervention. For example, a femoral de-rotation osteotomy may be performed to address the in-toeing gait observed in a child with cerebral palsy, or this procedure may be performed to correct the out-toeing gait pattern caused by a slipped capital femoral epiphysis fracture. These orthopaedic procedures are highly complex and involve multi-plane correction requiring a high level of surgical expertise and experience. In this project, we will: - Develop tools to rapidly produce personalised computational models of paediatric patients with bone deformities, - Develop technology to perform virtual surgical simulations to optimize surgical pre-planning, - Develop technology to simulate post-operative walking function, - Design and manufacture surgical cutting guides using 3D printing, - Utilize 3D printed surgical guides in surgery to streamline the translation of the virtual plan to surgical execution, - Evaluate surgical outcomes and accuracy of pre-operative surgical predictions of post-operative function. The primary aim of the proposed research is to determine the efficacy of virtual surgery and personalised cutting guides for the surgical treatment for children with bone deformity in Queensland. We expect the inclusion of virtual surgery and 3D printing of surgical guides will result in improved anatomical alignment and improved post operative walking kinematics.

This is a randomized, double-blind, 3-arm, parallel-group single-dose study to compare the PK, PD, safety, tolerability, and immunogenicity of LusiNEX (Mycenax tocilizumab) versus RoActemra (EU tocilizumab) and Actemra (US tocilizumab) after a single IV infusion of 4 mg/kg in healthy volunteers (hereafter referred to as subjects). The therapeutic dose of tocilizumab starts with 4 mg/kg and ranges to 12 mg/kg, considering 4 mg/kg is the lowest dose, the same has been selected for the study.

The mental health of young people is important now more than ever as mental health disorders have formed a significant burden in all societies (Patel, Flisher, Hetrick, & McGorry, 2007). Internalising disorders, such as anxiety and depression, are consistently reported as the most common mental health problems amongst Australian children aged between 7 and 14 years and are often less likely to be detected compared to externalising disorders (Australian Institute of Health, 2012; Klein, Jacobs, & Reinecke, 2007; Letcher, Sanson, Smart, & Toumbourou, 2012; Seligman, Ernst, Gillham, Reivich, & Linkins, 2009). However early intervention has been promising in preventing the trajectory of future diagnosable conditions as well as enabling adolescents to fulfil their potential Klein, et al., 2007; McGorry, Bates, & Birchwood, 2013). Perfectionism has recently gained attention for being a major aspect in sustaining the growth and maintenance of many disorders and underling a series of pathologies such as depression, social anxiety, generalized anxiety disorder, eating disorders and even personality disorders (Dimaggio et al., 2015; Holland, Bodell, & Keel, 2013). Perfectionism refers to a tendency to strive for flawlessness and set exceedingly high standards for performance, accompanied by tendencies for overly critical evaluations (Stoeber, Eklund, & Tenenbaum, 2014). Its trans diagnostic nature positions perfectionism to be an ideal target for early intervention. Self-compassion is a construct gaining prominence over recent years and shown to be an important predictor of wellbeing (Barnard & Curry, 2011) as well as directly targeting the key features of perfectionism (Neff, 2011; Neff & Germer, 2013; Neff, 2010). Self-compassion refers to treating oneself with care and understanding when facing personal mistakes, shortcomings and failures (Neff, 2003). Self-compassion has also been shown to be an effective intervention target for adolescents suffering from negative world views (Neff, 2010). Self-compassion looks to be a healthy way of targeting perfectionism. This intervention research project examines a self-compassion and CBT based program which is brief (delivered over x4 90 minute modules weekly). We are using a cohort-controlled trial to compare year 7 students who receive the intervention to year 6 students who act as a control group and complete the same outcome measures at the same time, but are not exposed to the intervention. We are interested in the efficacy of the program for mental health, perfectionism, self-compassion and emotion regulation outcomes.

The aim of this study is to assess the effectiveness of integrating consumer behaviour strategies such as menu labelling, positioning, feedback, incentives, prompts, and price into an online canteen ordering system in reducing the average energy, saturated fat, sugar and sodium content of student lunch orders. The study will employ a clustered randomised controlled design. NSW primary schools currently using an online canteen ordering system will be randomised in a 1:1 ratio to receive either the intervention or control (standard online ordering only). Intervention effectiveness will be assessed through a nutritional analysis of lunch order purchases recorded by the online ordering system at baseline and 12 months follow-up.

Errors in diagnosis, including delays and receiving an incorrect diagnosis, have serious consequences for patient safety and patient outcomes. Whilst system factors play a role in diagnostic errors, cognitive biases have been identified as being a significant contributor to diagnostic error. Evidence suggests that to address cognitive bias in diagnostic decision-making, getting a second opinion and asking questions designed to challenge bias may be effective at reducing diagnostic error. The purpose of this project is to address cognitive bias in diagnostic decision-making in Emergency Departments (ED). To do this, an intervention will be trialled which involves performing a second independent review of all abdominal pain cases presenting to Box Hill Hospital Emergency Department, followed by a structured discussion to prompt questions, broaden thinking and challenge assumptions. Following the first clinician’s assessment, an independent review will be conducted by a second clinician in the ED followed by a structured discussion between the first clinician and the second opinion. The second part of this intervention, the structured discussion, will be guided by a standard set of questions. Existing ED practices typically involve repeated ad hoc clinical examination by multiple clinicians, so it is anticipated that patients presenting to the ED with abdominal pain will not notice a change in their care, or find this process burdensome. References Blumenthal-Barby, J., & Krieger, H. (2014). Cognitive biases and heuristics in medical decision making: A critical review using a systematic search strategy. Medical Decision Making, 35(4), 539-557. Croskerry. (2003). The importance of cognitive errors in diagnosis and strategies to minimize them. Academic medicine, 78(8), 775-780. Graber, M. L., Franklin, N., & Gordon, R. (2005). Diagnostic error in internal medicine. Arch Intern Med, 165(13), 1493-1499.

This study is assessing the impact of an exercise program on quality of life and physical function in prostate cancer patients being treated with hormone therapy. Who is it for? You may be eligible for this study if you have biopsy proven prostate cancer and are currently on hormone therapy i.e. androgen deprivation therapy. Study details All participants will undertake an exercise program consisting of 3 one-on-one sessions with an exercise physiologist, followed by 14 weeks of group training and home-based exercises. Participants will answer a number of questionnaires, perform a number of physical function tests, and have their body composition assessed using a body composition scan. It is hoped this study will demonstrate the effectiveness of exercise in improving patient quality of life and daily function, particularly in patients from rural/regional settings.

The primary purpose of this study is to evaluate the clinical efficacy and safety of topical lidocaine spray in reducing neuropathic pain in patients with Postherpetic Neuralglia (PHN) compared with those on a placebo spray.

MYB is a randomised controlled trial of multiple online interventions designed to target modifiable risk factors for Alzheimer’s disease and dementia. Risk factors to be addressed are physical inactivity, cognitive inactivity, depression/anxiety, overweight and obesity, and poor diet. Up to four intervention modules (physical activity, nutrition, brain training and peace of mind) will be administered based on individual risk profiles. Each module will be initially delivered using MYB eHealth platform over 10 weeks. In this part of the intervention, participants complete their assigned modules back-to-back, noting that the total number of modules is variable depending on individual’s risk factors. In practice this will translate to a minimum of two modules and a maximum of four modules, over a maximum of 12 months. Booster sessions (specific to each module) and ongoing monitoring will then continue for three years. Follow-up assessments measuring these risk factors and cognition will be completed annually for three years. The control group (“information” group) will receive basic psychoeducation online about dementia risk factors via a website with set activities organised by corresponding module eligibility (i.e., information activities themed around peace of mind, brain training, nutrition and/or physical activity). They will otherwise undertake the same enrolment, baseline and annual follow-up assessments.

Hypothesis: We propose in patients with the dual phenotypes of severe allergic and eosinophilic asthma, that Mepolizumab is as effective as Omalizumab. However, we will also go on and identify key clinical biomarkers that will clarify which patients will respond best to each of these interventions. This study will be the first direct clinical comparison of these agents and will apply expert clinical characterization, along with cutting edge biotechnology to better inform treatment choices for severe asthma. This is an important and urgent management problem facing the Australian pharmaceutical scheme, where imprecision in prescribing will result in reduced clinical effectiveness as well as substantial and sustained costs.

This is an open-label, multi-center, dose-escalation phase I study. The primary purpose of this trial is to evaluate the safety and tolerability as well as the preliminary efficacy of KN046 in participants with advanced solid tumors. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have been diagnosed with advanced malignant solid tumor with no standard therapy is available. Study details All participants enrolled in this trial will receive KN046 intravenously every two weeks for 6 months or until excessive toxicity, disease progression, patient consent withdral, physician's judgment (whichever occurs first), up to 2 years. The dose received by each participant depends on the time of their enrolment. KN046 is a biological drug for treatment of advanced solid tumor. As a part of the clinical research study patients will have regular blood tests, physical examinations, Tumor imaging examinations by either CT or MRI. It is hoped this study will contribute important safety and efficacy information as well as to determined the optimal dose of KN046 to administer for treatment.